biological therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: interleukin-2 may stimulate a person's white blood cells including natural killer cells to kill prostate cancer cells. interferon gamma may interfere with the growth of the cancer cells. combining interferon gamma with interleukin-2 may be a more effective treatment for prostate cancer. purpose: phase i/ii trial to study the effectiveness of biological therapy using interleukin-2 and interferon gamma in treating patients with advanced prostate cancer.

objectives: i. evaluate the safety of immunization with hla class i-matched allogeneic human prostate carcinoma cells genetically engineered to secrete interleukin-2 and interferon gamma in patients with prostate carcinoma. ii. evaluate the antitumor effects of this treatment as assessed by post-therapy declines in psa. iii. evaluate the induction of cellular and humoral immunity in vivo with this treatment. outline: tumor cell vaccine therapy. immunization with irradiated, mhc class i-matched allogeneic human prostate carcinoma cells, lncap cells, engineered to secrete approximately 58 ng/24 hr/million cells of interleukin-2 (il-2) and approximately 0.72 u/24 hr/million cells of interferon gamma (ifn-g). projected accrual: up to 12 patients will be entered on the phase i study; accrual will continue to a total of 25 patients treated at the mtd (phase ii). accrual is expected to require 2 years.

Eligibility criteria:
disease characteristics: histologically confirmed prostate carcinoma for phase i: progressive, androgen-independent disease required, i.e.: elevated psa despite castrate testosterone levels (below 50 ng/dl) documented on 3 successive occasions for phase ii: progressive disease after surgery or radiotherapy without prior hormonal therapy also eligible hla-a1- or hla-a2-positive disease required measurable or evaluable disease required no active cns metastases patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: at least 12 weeks hematopoietic: wbc greater than 3,000 absolute lymphocytes greater than 1,000 platelets greater than 100,000 hb at least 9 g/dl hepatic: bilirubin less than 2.0 mg/dl or sgot less than 2 x uln renal: creatinine no greater than 2.0 mg/dl or creatinine clearance at least 40 ml/min cardiovascular: no nyha class iii/iv status pulmonary: no severe debilitating pulmonary disease other: no active infection requiring antibiotics not hiv positive no history of hypersensitivity to interferon gamma or other vaccine component no serious intercurrent medical illness prior concurrent therapy: recovered from toxicity of any prior therapy biologic therapy: no prior autologous or allogeneic tumor vaccines no concurrent other immunotherapy chemotherapy: at least 4 weeks since chemotherapy no concurrent chemotherapy endocrine therapy: flutamide discontinued and subsequent progression prior to entry 3 consecutive rising psa values at least 2 weeks apart no concurrent corticosteroids (except for life-threatening conditions) medical hormonal therapy to maintain castrate testosterone levels required in the absence of orchiectomy radiotherapy: at least 4 weeks since radiotherapy no concurrent radiotherapy surgery: prior surgery allowed

Keywords: recurrent prostate cancer